Benzinga | Aug 4, 2021 09:06AM EDT

Natera Reports Use Of Signatera As Companion Diagnostic In GlaxoSmithKline's Phase 3 ZEST Trial For Niraparib In Early-Stage Breast Cancer

-- Natera, Inc. (NASDAQ:NTRA), a pioneer and global leader in cell-free DNA testing, announced that the first patient has been screened in a new phase III trial that uses its personalized, tumor-informed molecular residual disease (MRD) test, Signatera, to identify early-stage breast cancer patients eligible for investigational treatment with GSK's PARP inhibitor niraparib (ZEJULA).



The ZEST study, sponsored by GSK, is a randomized, multicenter, phase III, placebo-controlled clinical trial to evaluate the efficacy and safety of treatment with niraparib following surgery or completion of adjuvant therapy in 800 patients with either triple-negative breast cancer or HR-positive/HER2-negative, BRCA-mutated breast cancer. After definitive upfront treatment, serial testing with Signatera will be used to identify patients who have detectable MRD to evaluate therapy with niraparib versus placebo in a setting where relapse is detected early ahead of radiologically defined disease progression.

"We are delighted to partner with GSK, a leader in oncology drug development, to help bring personalized medicine to patients with early-stage breast cancer," said Solomon Moshkevich, general manager of oncology at Natera. "Our vision is that early-stage breast cancer patients will be monitored regularly using Signatera, with access to effective treatment upon the detection of molecular recurrence."

This is the second phase III registrational trial to incorporate Signatera as a companion diagnostic. Signatera has been designated as a Breakthrough Device by the FDA for three different clinical indications, including one designation for the early-stage breast cancer intended use being evaluated in the ZEST trial.